A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study
- Conditions
- Post Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS)
- Registration Number
- EUCTR2006-000485-36-GB
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
1. Lung transplant recipient
2. Male or Female
3. Age 16 years or over
4. Airflow limitation – FEV1 < 80% maximum recorded post transplant
5. Ability to give Informed Consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Airflow limitation caused by other clinical problems (e.g clinical infection)
2. Known hypersensitivity to Azithromycin or any of the macrolide antibiotics
3. Participation in another drug related trial within 90days
4. Severe renal or hepatic impairment
5. Use of concomitant medication that would interact with azithromycin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method